FS TEST KIT
FDA 510(k) clearance K854015 · decided 1986-03-06
Clearance details
- K-number
- K854015
- Device name
- FS TEST KIT
- Applicant
- American Bioproducts Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-09-27
- Decision date
- 1986-03-06
- Days to decision
- 160 days
- Clearance type
- Traditional
- Product code
- JBN
- Device class
- 2
- Regulation number
- 864.7300
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parsippany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SULFATE, FIBRIQUIK PROTAMINE (K781814) | General Diagnostics | 1978-11-08 |
Recalls involving this device
No recalls on record reference this clearance.